Official Title
Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
Phase
Phase 2Lead Sponsor
Zhengzhou UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Premature InfantIntervention/Treatment
EPO ...Study Participants
1285This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.
NEC is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models. Evidence from previous clinical studies about the effect of EPO treatment against NEC have all been hampered by small numbers of patients. The study is to investigate whether repeated low-dose EPO protects against NEC. Preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to EPO (500IU/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). Primary outcome is the incidence of NEC at 36 weeks of corrected age. Secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with NEC.
Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.
Infants in control group are administered normal saline with the same volume and period as EPO.
Infants in the EPO group are given EPO 500IU/kg dissolved in 2 ml saline intravenously every other day for 2 weeks starting within 72 hours after birth.
Infants in the control group are given normal saline intravenously with the same volume as EPO every other day for 2 weeks.
Inclusion Criteria: Preterm infants with gestation age ≤ 32weeks Within 72 hours after birth Written informed consent obtained from parents Exclusion Criteria: Genetic or metabolic diseases Congenital abnormalities Polycythemia Intracranial hemorrhage grade III/IV Unstable vital signs (such as respiration and circulation failure)
